本文選題：藥事管理 + GMP　； 參考：《上海交通大學(xué)》2014年碩士論文

【摘要】：在生產(chǎn)和市場全球化的趨勢下,制藥行業(yè)的競爭愈演愈烈。與歐美制藥行業(yè)相比,國內(nèi)的藥事管理還處于初級階段,為了能夠在未來的競爭中立于不敗之地,我國制藥企業(yè)必須加強藥事管理方面的建設(shè),最主要的是加強現(xiàn)行藥品生產(chǎn)質(zhì)量管理規(guī)范CGMP(Current Good Manufacturing Practice)方面的控制,中國藥監(jiān)部門不斷地加大對藥品生產(chǎn)的監(jiān)管力度,以保證人民用藥安全。中國醫(yī)藥企業(yè)雖然已經(jīng)走過了GMP的初級階段,但與世界發(fā)達(dá)國家相比還有差距,認(rèn)真執(zhí)行并嚴(yán)格貫徹CGMP還有相當(dāng)長的路要走。本文通過對藥事管理及CGMP相關(guān)法律法規(guī)及文獻(xiàn)的深入研究,綜合分析了我國藥事管理及GMP的發(fā)展進(jìn)程,并與美國和歐盟等國的CGMP進(jìn)行比較,以期借鑒發(fā)達(dá)國家的經(jīng)驗,促進(jìn)我國CGMP的完善。本文第一章概括介紹了藥事管理和CGMP的概念。GMP是藥事管理活動在藥品生產(chǎn)方面的管理規(guī)范,是保證人們用藥安全的必須準(zhǔn)則,所以國內(nèi)外制藥企業(yè)必須通過CGMP認(rèn)證生產(chǎn)的藥品才能上市銷售。第二章介紹中國及歐美GMP的發(fā)展歷程。重點闡述了CGMP得以提出以及實行對制藥企業(yè)的必要性。第三章重點介紹我國新版GMP實施的現(xiàn)狀及與美國、歐盟的比較分析。給出具體的數(shù)據(jù)和示例,闡釋了新版GMP與美國在動態(tài)監(jiān)管及質(zhì)量風(fēng)險管理方面,與歐盟在細(xì)致性、深入性等方面的不同第四章對全文進(jìn)行了總結(jié),闡述了本文的主要論點及進(jìn)一步改善的的地方。
[Abstract]:In the trend of globalization of production and market, the competition of pharmaceutical industry is becoming more and more intense. Compared with the European and American pharmaceutical industry, the domestic pharmaceutical management is still in the initial stage, in order to be able to be invincible in the future competition, our pharmaceutical enterprises must strengthen the construction of pharmaceutical management. The most important thing is to strengthen the control of the current drug production quality management standard CGMP(Current Good Manufacturing Practice). The Chinese drug supervision department continuously strengthens the supervision of the drug production in order to ensure the safety of drug use by the people. Although Chinese pharmaceutical enterprises have passed through the initial stage of GMP, there is still a gap compared with the developed countries in the world, and there is still a long way to go to implement and strictly implement CGMP. Based on the in-depth study of pharmaceutical management and CGMP laws and regulations, this paper comprehensively analyzes the development process of drug management and GMP in China, and compares them with the CGMP of the United States and the European Union in order to learn from the experiences of developed countries, such as the United States of America and the European Union, in order to draw lessons from the experience of the developed countries. To promote the perfection of CGMP in China. In the first chapter of this paper, the concept of drug management and CGMP is introduced, which is the standard of drug management in drug production, and is the necessary criterion to ensure the safety of drug use. So domestic and foreign pharmaceutical enterprises must pass the CGMP certification production of drugs can be sold on the market. The second chapter introduces the development of GMP in China and Europe. The necessity of putting forward and implementing CGMP to pharmaceutical enterprises is emphasized. The third chapter focuses on the implementation of China's new GMP status and comparative analysis with the United States and the European Union. This paper gives specific data and examples, explains the new version of GMP and the United States in terms of dynamic regulation and quality risk management, and the European Union in detail, depth and other aspects of the different chapter IV summarized the full text. The main points of this paper and further improvement are expounded.
【學(xué)位授予單位】：上海交通大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2014
【分類號】：F426.72

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本文編號：1970787